NL-OMON21032招募中不适用
Safe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete (CR) or partial response (PR)
Erasmus MC Cancer Institute0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •For final inclusion in the trial, patients need to have a confirmed CR/PR according to RECIST v1.1 using a diagnostic CT, including a diagnostic CT at baseline
- •A potential subject who meets the following criteria can be screened for inclusion in this study:
- •-age = 18 year
- •-advanced or metastatic melanoma
- •-current treatment with first-line nivolumab or pembrolizumab for advanced or metastatic melanoma; previous systemic treatment, including immunotherapy, in (neo)adjuvant setting for resectable melanoma is allowed
- •oPlease note: if one of the PD-1 blockade treatments is replaced by the other because of a reason other than progression or non-response, e.g. because of infusion-related reactions, this is still considered first-line therapy and patients are still eligible for inclusion
- •-documented target lesion(s) according to RECIST v1.1 on diagnostic CT at start of PD-1 blockade with nivolumab or pembrolizumab
- •oFor patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline
- •oFor patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria. In this specific case, the sponsor should be consulted.
- •-documented tumor response evaluation every 12(+/-1) weeks according to RECIST v1.1 using a diagnostic CT as per standard practice
- •-presence of MRI brain for the screening of brain metastases (prior to discontinuation of PD-1 blockade)
- •-planned and willing to discontinue nivolumab or pembrolizumab within 6(+1) weeks after first confirmation of CR or PR before the full period of 2 years therapy
- •-signed and dated informed consent form
排除标准
- •concomitant systemic therapies with other anti-cancer agents, e.g. BRAF-inhibitor, anti-CTLA4 (e.g. ipilimumab), or other PD-1 blockade than nivolumab or pembrolizumab
研究者
相似试验
招募中
不适用
Safe Stop Trial: observational study of the STOP & GO strategy of PD-1 blockade in advanced melanoma patients upon achieving a complete or partial responseMelanomaNL-OMON55748Erasmus MC, Universitair Medisch Centrum Rotterdam200
尚未招募
不适用
A study on Stop-Start technique” on sexual satisfaction in persons affected by premature ejaculatioPremature ejaculationSLCTR/2013/004Dr. C M A Anthony .
招募中
不适用
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumabmalignant melanoma1002765610040900MelanomaNL-OMON53859Erasmus MC, Universitair Medisch Centrum Rotterdam80
尚未招募
不适用
A study to see if C-Reactive Protein is needed before stopping antibiotics in newborn babies suspected to have bacterial infection whose blood cultures are negativeCTRI/2016/06/007056Christian Medical College Hospital Vellore220
进行中（未招募）
1 期
A Long-term Extension Trial Investigating the Safety and Efficacy of GTX-102 in Patients with Angelman SyndromeAngelman SyndromeMedDRA version: 20.0Level: PTClassification code: 10049004Term: Angelman's syndrome Class: 100000004850CTIS2024-510917-14-00ltragenyx Pharmaceutical Inc.75